DEPARTMENT OF CONSUMER AND INDUSTRY SERVICES

                         RADIATION SAFETY SECTION

                            
(By authority conferred on the department  of  public  health  by  section
13521 of Act No. 368 of the Public Acts of 1978, as amended,  and  section
48 of  Act  No. 306  of  the  Public  Acts  of  1969,  as  amended,  being
SS333.13521 and 24.248 of the Michigan Compiled Laws)


                          PART 14. MAMMOGRAPHY

                           GENERAL PROVISIONS


R  325.5601   Purpose and scope.
  Rule 601. (1) This part establishes requirements governing  the  use  of
x-radiation for mammography and apply to all persons who  use  x-radiation
for mammography for the intentional exposure of humans. A person shall not
use a radiation  machine  to  perform  mammography  unless  the  radiation
machine is registered with the department pursuant to the provisions of  R
325.5181  to  R  325.5196  and  is  specifically  authorized  to   perform
mammography pursuant to the provisions of the act.
  (2) In addition to the  requirements  of  this  part,  all  persons  are
subject to the provisions of R 325.5001 to R 325.5511.
  (3) A facility shall not misrepresent to its employees, to  the  public,
or to the department its status  with  respect  to  accreditation  of  the
mammography equipment by the American  college  of  radiology,  department
authorization to perform mammography, or compliance with department rules.

  History:  1993 AACS.


R  325.5602   Definitions.
  Rule 602. (1) As used in this part:
  (a) "Act" means sections 13501 to 13536 of Act No.  368  of  the  Public
Acts of 1978, as amended, being SS333.13501 to 333.13536 of  the  Michigan
Compiled Laws.
  (b) "Annual" means a period of time that is not more than 365 days.
  (c) "Asymptomatic" means without signs or symptoms of breast disease.
  (d) "Automatic exposure  control"  means  a  device  that  automatically
controls 1 or more technique factors to  obtain  a  required  quantity  of
radiation at a preselected location or locations.
  (e) "Compression device" means a rigid  apparatus  that  compresses  the
breast to immobilize the  breast  and  provide  uniform  thickness  during
mammography.
  (f) "Cranio-caudal" means a  mammographic  projection  where  the  image
receptor is placed inferior to the breast and the x-ray beam  is  directed
superior to inferior through the breast.
  (g) "Diagnostic  mammography"  means  the  mammographic  examination  of
symptomatic individuals.
  (h) "Diagnostic physics" means the branch of medical physics that  deals
with the diagnostic applications of ionizing radiation and  the  equipment
associated with its production and use.
  (i) "Focal spot" means the primary source  of  x rays  produced  at  the
location where the anode of an x-ray tube intercepts the electron beam.
  (j) "Grid" means a device which is used to control  scattered  radiation
and which is  composed  of  alternating  strips  of  high-x ray-absorption
material and low-x ray-absorption spacer material encased in a  protective
cover.
  (k) "Mammography" means radiography of the breast  for  the  purpose  of
enabling a physician to determine the presence, size, location, and extent
of cancerous or potentially cancerous tissue in the breast.
  (l) "Mammography phantom" means a device that is designed  to  attenuate
the x-ray beam in a similar way as a  typical  compressed  breast  and  to
simulate breast tissue pathology.  A  mammography  phantom  contains  test
objects that simulate microcalcifications, fibers, and tumor masses and is
used both in the determination of typical patient radiation exposures  and
to evaluate imaging performance. X-ray images of the phantom are evaluated
in terms of the  number  of  the  test  objects  of  each  type  that  are
visualized under standard viewing conditions.
  (m) "Mammography supervisor" means the  individual  who  is  responsible
for, and in  control  of,  quality  control,  radiation  safety,  and  the
technical  aspects  of  all  x-ray  examinations  and  procedures  for   a
mammography machine and a mammography facility.
  (n) "Radiological physics" means the  branch  of  medical  physics  that
includes diagnostic physics,  therapeutic  physics,  and  medical  nuclear
physics.
  (o) "Screen-film mammography" means mammography in which  the  image  is
recorded on x-ray film that is used in conjunction  with  an  intensifying
screen or screens.
  (p) "Screening mammography" means the periodic mammographic  examination
of asymptomatic women to detect unsuspected breast cancer in its  earliest
stage.
  (q) "Xeromammography" means mammography in which the image  is  recorded
on an electrostatically charged photoconductive plate that is  held  in  a
lightproof cassette.
  (2) The terms defined in the act shall have the same meanings when  used
in these rules.

  History:  1993 AACS.


R  325.5603   Department inspections.
  Rule 603. (1) The department shall inspect  a  mammography  machine  and
system not later than 60 days after initial mammography  authorization  is
issued. After that  initial  inspection,  the  department  shall  annually
inspect  the  mammography  machine  and  system  and  may   inspect   more
frequently.
  (2) After each satisfactory inspection by the department, the department
shall issue a certificate of radiation machine inspection which identifies
the facility and the machine inspected and which provides a record of  the
date that the machine was inspected. The facility shall conspicuously post
the certificate on or near the inspected machine and in a location that is
observable by patients.
  (3) The department may issue  a  notice  of  violations  certificate  if
violations found  during  an  inspection  are  not  corrected  within  the
specified time limit  or  if  the  department  has  not  received  written
verification of corrections within the specified time limit. The notice of
violations certificate shall  be  conspicuously  posted  on  or  near  the
inspected machine and in a location observable by patients.
  (4) A  facility  shall  remove  the  certificate  of  radiation  machine
inspection if directed by the department due to subsequent failure  to  be
in  compliance  with  this  part  and  the  provisions  of  R 325.5001  to
R 325.5511 as determined by follow-up inspections by the department.
  (5) In conducting inspections, the department shall have access  to  all
equipment,  materials,  records,  personnel,  and  information  that   the
department considers necessary to determine compliance with  these  rules.
The department may  copy,  or  require  the  facility  to  submit  to  the
department, any of  the  materials,  records,  or  information  considered
necessary to determine compliance with these rules.
  (6) The department  shall  designate  department  employees  to  conduct
regulatory inspections.
  (7) The department may conduct tests and evaluations as  the  department
deems appropriate to determine compliance with all of  the  provisions  of
this part and the provisions of R 325.5001 to R 325.5511.

  History:  1993 AACS.


                         MAMMOGRAPHY AUTHORIZATION


R  325.5605   Standards for authorization.
  Rule 605. The department shall issue a 3-year mammography  authorization
if the mammography facility is in compliance with  all  of  the  following
standards:
  (a) The radiation machine is in compliance with either of the  following
requirements:
  (i) The machine meets the criteria for the American college of radiology
mammography accreditation program dated October, 1991, and January,  1992,
and the facility submits an  evaluation  report  issued  by  the  American
college of radiology as evidence that the mammography  machine  meets  the
criteria. The criteria are adopted by reference in  these  rules  for  the
purpose of applying this  paragraph  only.  Copies  of  the  criteria  are
available at no cost from the Division of  Radiological  Health,  Michigan
Department of Public Health, 3423 North  Martin  Luther  King,  Jr. Blvd.,
P.O. Box 30195, Lansing, Michigan 48909.
  (ii) The machine is used in a facility that has  successfully  completed
the department's evaluation of the machine  for  the  items  described  in
R 325.5610.
  (b) The radiation machine, the film, or other  image  receptor  that  is
used with the machine and the facility where the machine is  used  are  in
compliance  with  the  requirements  of  this  part  and   R 325.5001   to
R 325.5511.
  (c)  The  radiation  machine  is  specifically   designed   to   perform
mammography.
  (d) The radiation machine is used exclusively to perform mammography.
  (e) The radiation machine is used in a facility that, at least annually,
has a qualified radiation physicist provide on-site  consultation  to  the
facility as described in these rules.  Records  and  findings  of  on-site
consultations shall be maintained for not less than 7 years.
  (f) The radiation machine is  used  according  to  department  rules  on
patient exposure and radiation dose levels, being R 325.5661 of this part.
  (g) The radiation machine is operated only  by  an  individual  who  can
demonstrate to the department that he or she meets the standards described
in this part or by an individual who is  a  physician  or  an  osteopathic
physician.

  History:  1993 AACS.


R  325.5606   Temporary mammography authorization.
  Rule  606.  (1)  The  department  may  issue  a  nonrenewable  temporary
mammography authorization. A temporary authorization may only be issued if
additional time is needed to allow the  submission  of  evidence  that  is
satisfactory  to  the  department  to  demonstrate  compliance  with   the
provisions of R 325.5605.
  (2) The department may withdraw a  temporary  authorization  before  its
expiration if the radiation machine  does  not  meet  1  or  more  of  the
criteria specified in R 325.5605.

  History:  1993 AACS.


R  325.5607   Application.
  Rule 607. (1) Each person who has a machine that is authorized  for  use
for mammography on the effective date of this part shall  be  required  to
complete a mammography authorization application form if requested by  the
department. This application form shall  be  returned  to  the  department
within 45 days of the department's request.
  (2) An applicant who seeks mammography authorization shall apply to  the
department using an application form that is supplied by  the  department.
If mammography is performed at more than 1 location or address, a separate
application shall be used for each location or address. An applicant shall
accurately provide all information that is  requested  on  the  form.  The
information submitted as part of the application shall be  sufficient,  as
determined by  the  department,  to  address  all  of  the  standards  for
authorization. Applications that do  not  provide  sufficient  information
shall be returned  to  the  applicant  for  completion  and  resubmission.
Applications shall include all of the following information:
  (a) Information about the facility, including all of the following:
  (i) Name, address, and telephone number.
  (ii) Type of practice.
  (iii) The name to be used or which is currently used on the  certificate
of registration.
  (b)  Personnel   information,   including   the   education,   training,
experience, and certification of the mammography supervisor, any qualified
radiation physicist who provides on-site consultation  and  evaluation  of
the  mammography  system,  and  any  individual  who   actually   performs
mammography.
  (c) Mammography machine technical  information,  including  all  of  the
following:
  (i) Manufacturer.
  (ii) Model.
  (iii) Year of manufacture.
  (iv) The imaging system in use.
  (v) Target material.
  (vi) Filter material.
  (vii) Phototiming capability.
  (viii) The nominal focal spot size.
  (ix) The source-to-image distance.
  (x) The half-value layer.
  (xi) The type of compression device used.
  (xii) The capability of magnification studies.
  (xiii) The grid availability and type.
  (xiv) The grid ratio.
  (xv) Grid lines per inch or per centimeter.
  (xvi) Film size and grid size capability.
  (xvii) The make and model of film and screens.
  (d) Image processor information, including all of the following:
  (i) The manufacturer.
  (ii) Model.
  (iii)  Whether  the  processor  is  dedicated   to   mammography   image
processing.
  (iv) Chemistry type.
  (v) Temperature.
  (vi) Development time.
  (e) Mammography techniques, including all of the following:
  (i) Number of views per breast.
  (ii) Typical views employed.
  (iii) Machine settings for routine mammograms.
  (iv) Grid use.
  (f) A copy of the facility's mammography quality  assurance  plan  which
includes a description of all of the following:
  (i) Quality control tests performed.
  (ii) The frequency of tests.
  (iii) By whom the tests are performed.
  (iv) The limits of acceptability of those tests.
  (v) The protocol for making corrections when a test does not fall within
the limits of acceptability.
  (g) The type of patient medical history  information  collected  by  the
facility, including whether a history is taken as part of the mammographic
procedure and, if taken, the items that are included in the history.
  (h) The type of patient physical examination  information  collected  by
the facility, including all of the following:
  (i) Whether a physical examination is conducted and, if so, by whom.
  (ii) The  training  the  individual  has  specific  to  breast  physical
examination.
  (iii) Whether the  patient  is  instructed  in  breast  self-examination
during the physical examination or at any time by staff of  the  facility.
  (i) Mammography interpretation reporting mechanisms,  including  all  of
the following:
  (i) A description of whether the report includes both  mammographic  and
clinical findings.
  (ii) A description of the mechanism in place to follow up on positive or
equivocal results to assure that a patient's physician  has  received  the
report and understands any recommendations.
  (iii) An indication of whether patients who have equivocal  results  are
contacted for a follow-up examination at a prescribed time.
  (iv) A description of procedures for handling self-referred patients  in
terms of sending a report.
  (v) A description of the follow-up  mechanisms  in  place  to  determine
factors such as the results  of  biopsies,  the  number  of  cancers  with
negative  and  positive  mammograms,  the  number  of  localizations  with
positive results, and the proportion of cases for which  additional  views
are done.
  (j) Image retention policy.
  (3) The department shall respond to an application within 30 days  after
the date of receipt of the application.

  History:  1993 AACS.


R  325.5608   Application fee schedule; waiver.
  Rule 608. (1) An application form for mammography authorization shall be
accompanied by a nonrefundable payment, in full,  by  the  applicant,  for
department evaluation of compliance with the provisions of R  325.5605(a).
The fee schedule is specified in the act.
  (2) If an applicant for mammography authorization submits an  evaluation
report which is issued by the American  college  of  radiology  and  which
evidences compliance with the provisions of R 325.5605(a),  then  the  fee
for  department  evaluation  of  compliance  with  the  provisions  of   R
325.5605(a) shall be waived.

  History:  1993 AACS.


R  325.5609   Application expiration.
  Rule 609. An application for mammography authorization submitted to  the
department shall expire 6 months from the date of the department's receipt
of the completed application unless the time  limit  is  extended  by  the
department.

  History:  1993 AACS.


R  325.5610   Supplemental  machine  information;  effect  of  failure  to
submit information.
  Rule 610. (1) Upon notice from the department that  an  application  for
mammography authorization has been determined to be complete and to be  in
compliance with the requirements  of  these  rules  and  at  the  specific
request of the department, the applicant shall,  within  45  days  of  the
department's request, provide all of the following  information  for  each
machine for which mammography authorization is being sought:
  (a) Confirmation that a mammography phantom  that  is  approved  by  the
department is on-site when mammography is performed and  is  used  in  the
facility's ongoing quality control program. The confirmation shall include
the make, model, and serial number of the phantom and the serial number of
the wax insert that contains imaging test objects.
  (b) For each machine, processor  quality  control  data  and  corrective
actions, if any, taken as a result  of  that  data  for  a  30-day  period
beginning after the date the application was sent to the department.
  (c) For each machine, an x-ray image of a mammography phantom  which  is
approved by the department and which is taken during the 30-day period for
which  processor  quality  control  data  is  required  pursuant  to   the
provisions of subdivision (b) of this subrule. The phantom image shall  be
taken using routine machine settings being used by the facility  for  that
mammography  machine  for  a  cranio-caudal  view  of   a   4.5-centimeter
compressed breast composed of 50% glandular and 50%  adipose  tissue.  The
phantom image shall be accompanied by documentation of the date  that  the
image was taken and the machine settings that were used.
  (d) For each machine, determinations of the half-value layer,  radiation
exposure at skin entrance, and mean glandular dose that are made with  the
use of a department-approved thermoluminescent dosimetry  device  that  is
placed on top of an approved mammography phantom during the same  exposure
of the phantom that is used to produce an  x-ray  image  to  be  submitted
pursuant to the provisions of subdivision (c) of this subrule or that  are
made by other methods as specified or approved by the department.
  (e) For each machine, a  set  of  clinical  patient  mammography  images
without pathology which  is  produced  by  that  machine  for  each  of  2
representative patients, 1 with dense breasts and 1  with  fatty  breasts.
Each set of clinical images shall consist of  not  less  than  2  standard
views of each breast, totaling not less than 4  films  for  each  type  of
breast. The images  shall  contain  clear  documentation  of  all  of  the
following:
  (i) The name of the facility.
  (ii) The date of the mammography examination.
  (iii) Mammography machine operator identification information.
  (iv) Cassette-screen or xeroradiographic  cassette-plate  identification
information.
The date of the mammography examination shall be on or after the date that
the application was sent to the department, and the x-ray images shall  be
accompanied by  clear  documentation  of  the  mammography  machine  used,
including the department-assigned machine  registration  number,  and  the
name of the individual or individuals who operated the machine.
  (2) The department may waive the requirements of  subrule  (1)  of  this
rule if the mammography machine is accredited, or is  in  the  process  of
becoming accredited, by the American college of  radiology.  To  have  the
requirements of subrule (1)  of  this  rule  waived,  an  applicant  shall
provide, to the department, within 45 days of  the  department's  request,
copies of  the  applicant's  current  accreditation  application,  current
accreditation-related correspondence to and from the American  college  of
radiology, or current accreditation certificate  that  is  issued  by  the
American college of radiology.
  (3) Failure of an applicant to submit the information  required  by  the
provisions of either subrule (1) or (2) of this rule within 45 days of the
department's request may be considered a basis for withdrawal or denial of
the mammography authorization, unless the time limit is  extended  by  the
department for cause.

  History:  1993 AACS.


R  325.5611   Contracts for technical evaluation.
  Rule 611. (1) In evaluating clinical image quality and acceptability for
mammography authorization, upon receipt of the information required  in  R
325.5610(1)(e), the department may enter into any necessary contracts with
mammography experts, submit the images  to  those  experts  for  technical
evaluation, and rely  upon  their  expert  evaluation  in  arriving  at  a
department conclusion regarding image quality and acceptability  in  terms
of granting or not granting mammography authorization.
  (2) Technical parameters that are  used  in  evaluating  clinical  image
quality and acceptability pursuant to the provisions  of  subrule  (1)  of
this rule shall include judgments of all of the following:
  (a) Positioning.
  (b) Compression.
  (c) Radiation exposure and dose level.
  (d) Sharpness.
  (e) Contrast.
  (f) Noise.
  (g) Exam identification.
  (h) Artifacts.
  (i) Processing.

  History:  1993 AACS.


R  325.5612   Notice of change in application  information;  authorization
not transferable.
  Rule 612. (1) A facility that is authorized to perform mammography shall
notify the department, in  writing,  of  any  change  in  the  information
contained  in  the  application  or   supporting   material   upon   which
authorization was granted or any  change  that  affects  the  accuracy  of
information which is provided  or  obtained  during  the  application  and
evaluation process for  authorization.  Changes  that  shall  be  reported
include changes in any of the following:
  (a) Facility ownership.
  (b) Facility location.
  (c) Mammography machine.
  (d) Image processor.
  (e) Brand or model of imaging materials in use.
  (f) Personnel providing mammography supervision.
  (g) Personnel providing interpretation of mammograms.
  (h) Personnel providing qualified radiation physicist services.
  (i) Personnel actually performing mammography.
  (j) American college of radiology accreditation status.
  (2) Upon receipt of a notice of change, the department shall advise  the
facility if reapplication for mammography  authorization,  resubmittal  of
phantom or clinical images, or other actions are deemed by the  department
to be necessary to establish  that  the  facility,  machine,  system,  and
personnel remain in compliance with the requirements of these rules.  Upon
department request, a facility shall provide any requested information  or
materials within 45 days after the request is made.
  (3) If changes in information are deemed to  require  reapplication  for
mammography authorization, the application shall be filed and processed in
the same manner as set forth in R 325.5607 and R 325.5608.
  (4) Mammography authorization that is issued by the  department  is  not
transferable between machines or  between  persons  who  own  or  lease  a
radiation machine.

  History:  1993 AACS.


R  325.5613   Authorization withdrawal; reinstatement.
  Rule  613.  (1)  Three-year  mammography  authorization  is  subject  to
continued compliance with this part and the provisions  of  R 325.5001  to
R 325.5511.  Authorization  may  be  withdrawn  based   on   evidence   of
noncompliance  with  this  part  and  the  provisions  of  R 325.5001   to
R 325.5511 in accordance with the provisions of Act No. 306 of the  Public
Acts of 1969, as amended, being S24.201 et seq. of the  Michigan  Compiled
Laws.
  (2) If the department  withdraws  the  mammography  authorization  of  a
machine, the machine shall not be used for mammography. An application for
reinstatement of a mammography authorization shall be filed and  processed
in the  same  manner  as  an  application  for  mammography  authorization
pursuant to the provisions of R 325.5607 and R 325.5608.
  (3)  The  department  shall   not   issue   a   reinstated   mammography
authorization until the department receives the reinspection fee, inspects
the machine, and determines that the  facility  meets  the  standards  set
forth in R 325.5605.

  History:  1993 AACS.


                          MAMMOGRAPHY SUPERVISOR


R  325.5617   Designation; identification;  agreement  between  supervisor
and facility; availability; continuing education.
  Rule 617. (1) Each mammography facility shall  designate  a  mammography
supervisor in order to be authorized to perform mammography.
  (2) An applicant who seeks mammography authorization shall identify  the
mammography  supervisor  on   the   application   form   for   mammography
authorization.
  (3) If the mammography supervisor is not the employer of the mammography
machine operators at the facility, a written agreement shall  be  executed
between the mammography supervisor and the facility. The written agreement
shall include at least both of the following:
  (a) A statement that  the  mammography  supervisor  is  responsible  for
assuring compliance with this part and the provisions of R 325.5001  to  R
325.5511.
  (b) A statement that the  mammography  supervisor  has  been  given  the
authority to make changes in the mammography program that are necessary to
achieve compliance as specified in subdivision (a) of this  subrule  or  a
statement that the  facility  will  make  the  changes  requested  by  the
mammography supervisor to achieve compliance.
  (4) A mammography supervisor shall be readily  available  telephonically
or in person for consultation with  any  radiation  machine  operator  who
performs mammography.
  (5) A mammography supervisor shall obtain not  less  than  15  hours  of
continuing education every 3 years in the technical  aspects  or  clinical
aspects, or both, of mammography and related subjects that  is  accredited
by the American medical association or the American society of  radiologic
technologists or any other organizations acceptable to the department.

  History:  1993 AACS.


R  325.5618   Responsibilities.
  Rule 618. A mammography supervisor shall be responsible for each of  the
following:
  (a) Establishment and maintenance of a quality control program.
  (b) Annual review and updating of the procedures manual.
  (c) Evaluation of each mammography  machine  operator's  performance  at
least semiannually as described in R 325.5619.
  (d) Assurance that  each  mammography  machine  operator  other  than  a
physician has  successfully  completed  special  mammography  training  as
specified in R 325.5621 and R 325.5623 or possesses the American  registry
of radiologic technologists  certificate  of  advanced  qualifications  in
mammography as identified in R 325.5622. Documents  that  verify  training
shall be maintained at the facility and copies shall be submitted  to  the
department together with the facility application for mammography  machine
authorization.
  (e) Assurance that the mean glandular dose for 1  contact  cranio-caudal
view of a  4.5-centimeter  compressed  breast  that  is  composed  of  50%
glandular and 50% adipose tissue is not more than the limits prescribed by
R 325.5661.
  (f) Assurance that mammography is performed only on dedicated  equipment
that is designed specifically for use for mammography and  that  has  been
authorized by the department for use for mammography.
  (g)  Assuring  that  all  patients  who  undergo  mammography  screening
procedures designate a physician or other licensed  health  care  provider
responsible  for  primary  care,  to  whom  the  written  results  of  the
mammography examination will be reported.
  (h) Assuring  the  review  of  records  of  mammography  system  quality
assurance evaluations conducted by a qualified  radiation  physicist  and,
when necessary, assuring the correction of deficiencies and violations.
  (i) Compliance with quality assurance and radiation protection  criteria
prescribed by these rules.

  History:  1993 AACS.


R  325.5619   Machine operator performance evaluation.
  Rule 619. (1) A mammography supervisor shall evaluate the performance of
each individual, other  than  a  physician,  who  operates  a  mammography
machine at least semiannually. The evaluation shall be based on  both  the
mammography supervisor's direct  observation  of  the  operator  during  a
standard mammography procedure being performed by the operator on at least
1 patient and on the mammography supervisor's review of  clinical  images.
  (2) The performance evaluation shall evaluate all of the following:
  (a) Proper and compassionate patient handling skills.
  (b) Proper breast positioning for the cranio-caudal  projection  of  the
breast, including all of the following steps, unless other procedures  are
deemed appropriate and acceptable by the department:
  (i) Determining the proper image receptor size.
  (ii) Moving the photocell to the appropriate position.
  (iii) Standing on the medial side of the breast to be imaged.
  (iv) Elevating the inframammary fold to its  maximum  height,  adjusting
the height of the bucky accordingly.
  (v) Using 1 hand, gently scooping the breast  onto  the  image  receptor
tray.
  (vi) Centering the  breast  over  the  photocell,  with  the  nipple  in
profile, if possible.
  (vii) Anchoring the breast with 1 hand and not removing the  hand  until
the compression process begins.
  (viii) With the other hand, draping the opposite breast over the  corner
of the bucky.
  (ix) Slightly rotating the patient's  head  away  from  the  side  being
imaged.
  (x) Leaning the patient toward the machine with  the  head  forward  and
around the tube.
  (xi) Placing an arm against the  patient's  back  with  a  hand  on  the
shoulder of the side being imaged, making sure the shoulder is relaxed.
  (xii) With a hand  on  the  shoulder,  sliding  the  skin  up  over  the
clavicle.
  (xiii) With the hand that is anchoring the breast pulling lateral tissue
onto the image receptor tray, without losing medial tissue, while applying
compression.
  (xiv) On the side being imaged,  checking  that  the  patient's  arm  is
relaxed by her side with the shoulder externally rotated.
  (c) Proper breast positioning for the medio-lateral  oblique  projection
of the  breast,  including  all  of  the  following  steps,  unless  other
procedures are deemed appropriate and acceptable by the department:
  (i) Determining the proper image receptor size.
  (ii) Moving the photocell to the appropriate position.
  (iii) Determining the degree  of  obliquity  parallel  to  the  pectoral
muscle.
  (iv) Rotating the C-arm so that the long edge of the bucky  is  parallel
to the pectoral muscle.
  (v) Adjusting the height of the film tray so that the top is level  with
the axilla.
  (vi) Lifting the arm on the side to be imaged up and over the corner  of
the bucky.
  (vii) Placing the corner of the bucky in axilla, that  is,  anterior  to
the latissimus dorsi.
  (viii) Placing the patient's hand that is on the side  being  imaged  on
the C-arm, with the elbow flexed and the shoulder relaxed.
  (ix) Pulling the breast and muscle anteriorly and medially with the flat
front surface of the hand.
  (x) Scooping the breast tissue up with the hand,  grasping  the  lateral
border of the breast with the fingers and the medial border of the  breast
with the thumb.
  (xi) Turning the patient toward the bucky making sure that the patient's
feet are facing the machine.
  (xii) Centering the breast with the nipple in profile, if possible.
  (xiii) Holding the breast up and out by rotating the hand  so  that  the
base of the thumb supports the breast and so that the fingers are pointing
away from the breast  and  continuing  to  hold  the  breast  up  and  out
throughout compression.
  (xiv) Applying compression with the  corner  of  the  paddle  below  the
clavicle.
  (xv) Pulling down on the abdominal tissue to open the inframammary fold.
  (d) The use of appropriate compression.
  (e) Proper technique factor selection for  the  patient  being  x-rayed,
including selecting the proper kVp-target-filter combination for the image
receptor being used.
  (f) Proper maintenance of records, including examination  identification
information.
  (g) Familiarity with image processor quality  assurance  procedures  and
mammography machine quality assurance procedures that  are  applicable  to
the machine operator, including the use of  a  mammography  phantom  as  a
means of evaluating machine performance.
  (h) Knowledge of each of the following:
  (i) The American  college  of  radiology  accreditation  status  of  the
machine.
  (ii) The most recent department inspection of the machine and regulatory
inspection frequency.
  (iii) The most recent consulting physicist evaluation of the mammography
system and the frequency of those evaluations.
  (iv) The radiation dose for an average patient.
  (v) The recent phantom image results for the machine being used.
  (i) The ability  to  produce  acceptable  clinical  mammography  images.
Clinical images shall be evaluated on the basis of all  of  the  following
criteria:
  (i) Positioning.
  (ii) Compression.
  (iii) Optical density.
  (iv) Sharpness.
  (v) Contrast.
  (vi) Noise.
  (vii) Exam identification.
  (viii) Artifacts.
  (3) A machine operator performance evaluation shall be  recorded  on  an
evaluation form which includes all of the items described in  subrule  (2)
of this rule and which contains all of the following information:
  (a) The names and signatures of the mammography supervisor  and  machine
operator.
  (b) The date of the mammography examination for which the  operator  was
evaluated.
  (c) Examination and x-ray image identification information.
  (d) The date the evaluation results were discussed with the operator.
The form shall also document that the operator has received a copy of  the
evaluation.
  (4) A mammography  supervisor  shall  formally  discuss  the  evaluation
results with the operator within 10 days of observation.  A  copy  of  the
evaluation form shall be given to the operator at the time the  evaluation
results are discussed.
  (5) If an individual fails to receive a satisfactory evaluation for  any
item specified in subrule (2) of this rule, the individual  shall  receive
additional  training  pertaining  to  the  deficient  item  and  shall  be
reevaluated within 60 days of the original evaluation.
  (6) A  facility  shall  maintain  each  evaluation  form  on  permanent,
available file for a period of not  less  than  7  years.  Copies  of  the
evaluation forms shall be forwarded to the department for  review  upon  a
written request by the department.
  (7) Upon termination of employment,  an  operator  may  request  that  a
facility provide copies  of  the  operator's  evaluation  reports  to  the
operator or to another designated  individual.  Upon  written  request,  a
facility shall  provide  evaluation  reports  to  an  employee  or  former
employee for the 7-year period prior to the date of the request.

  History:  1993 AACS.


                    OPERATORS OF MAMMOGRAPHY EQUIPMENT


R  325.5621   Qualifications.
  Rule 621.  An  individual,  other  than  a  physician,  who  operates  a
mammography machine shall meet all of the following qualifications:
  (a)  An  individual  who  operates  a  mammography  machine  shall  have
successfully completed a radiography program that meets the standards  for
accrediting radiography programs adopted by the committee on allied health
education and accreditation, or its successor,  of  the  American  medical
association in cooperation with the joint review committee on education in
radiologic technology, entitled "Essentials and Guidelines," (1990). These
standards are adopted by reference in these  rules.  These  standards  are
available from the Division of Radiological Health, Michigan Department of
Public Health, 3423 North Martin Luther King, Jr. Blvd., P.O.  Box  30195,
Lansing, Michigan 48909, and from the American  Medical  Association,  515
North State Street, Chicago, Illinois 60610, at no charge at the  time  of
adoption of this part. Accreditation  of  a  radiography  program  by  the
committee on allied health education and  accreditation  of  the  American
medical association in cooperation with  the  joint  review  committee  on
education in radiologic technology shall be prima facie evidence that  the
radiography program  is  in  compliance  with  the  standards  adopted  by
reference in this subdivision.
  (b) An individual who operates a  mammography  machine  shall  meet  the
standards for issuance of  a  registration  certificate  as  a  registered
technologist from the American registry  of  radiologic  technologists  or
meet the standards  for  issuance  of  a  registration  certificate  as  a
radiography  technologist  from  the   American   registry   of   clinical
radiography  technologists.   These   standards,   entitled   "Rules   and
Regulations," as revised in February, 1990, and "By-Laws," as  revised  in
September, 1989, of the American registry of radiologic technologists  and
"Overview of the A.R.C.R.T. Organization," as revised in August, 1991, and
"Application for Registration Radiography Technologist,"  (1991),  of  the
American registry of clinical radiography technologists,  are  adopted  by
reference in this rule. These standards are available from the Division of
Radiological Health, Michigan Department  of  Public  Health,  3423  North
Martin Luther King, Jr. Blvd., P.O. Box 30195, Lansing, Michigan 48909, at
no charge at the time of adoption of this part. The  respective  standards
are also available from the American Registry of Radiologic Technologists,
1255 Northland Drive, Mendota  Heights,  Minnesota  55120,  and  from  the
American Registry of Clinical Radiography Technologists, 710 Higgins Road,
Park Ridge, Illinois 60068, at no charge at the time of adoption  of  this
part. A determination by the American registry of radiologic technologists
or the American registry of clinical  radiography  technologists  that  an
individual meets its respective standards for issuance of  a  registration
certificate shall be prima facie evidence  that  the  individual  complies
with the standards that are adopted by reference in this subdivision.
  (c) Two years  after  the  effective  date  of  this  part,  shall  have
successfully completed a formal  program  of  mammography  instruction  as
prescribed by R 325.5625.

  History:  1993 AACS.


R  325.5622   Technologist exemptions.
  Rule 622. (1) An individual who meets  the  standards  of  the  American
registry of radiologic  technologists  for  its  certificate  of  advanced
qualification in mammography shall be exempt  from  the  provisions  of  R
325.5621(c).  The  standards,  entitled  "Handbook  For   Advanced   Level
Examinations," (November, 1991), are adopted by reference  in  this  rule.
These standards are available from the Division  of  Radiological  Health,
Michigan Department of Public  Health,  3423  North  Martin  Luther  King,
Jr. Blvd., P.O. Box 30195, Lansing, Michigan 48909, and from the  American
Registry  of  Radiologic  Technologists,  1255  Northland  Drive,  Mendota
Heights, Minnesota 55120, at no charge at the time  of  adoption  of  this
part. A determination by the American registry of radiologic technologists
that an individual meets the standards for issuance of  a  certificate  of
advanced qualification in mammography shall be prima facie  evidence  that
an individual meets the standards adopted by reference  in  this  subrule.
However, the technologist shall be required to obtain continued  education
as prescribed by R 325.5623 and meet performance  requirements  prescribed
by R 325.5619(2).
  (2) Students in a radiography program that is  in  compliance  with  the
requirements of R 325.5621(a) shall be exempt from  the  provisions  of  R
325.5621  while  performing  mammography  within  the   context   of   the
radiography program and  under  the  direct  supervision  of  a  qualified
mammography  equipment  operator.  Registry  eligible  graduates   of   an
accredited radiography program that is in compliance with the requirements
of R 325.5621(a) shall be exempt from the provisions of R 325.5621(b)  and
(c) for 2 years after graduation.

  History:  1993 AACS.


R  325.5623   Continuing education.
  Rule 623.  An  individual,  other  than  a  physician,  who  operates  a
mammography machine shall, every 3 years, obtain not less than 15 hours of
continuing education in the technical  aspects  or  clinical  aspects,  or
both, of mammography and  related  subjects  that  is  accredited  by  the
American  medical  association  or  the  American  society  of  radiologic
technologists or any other organizations acceptable to the department.

  History:  1993 AACS.


R  325.5624   Operator prohibitions.
  Rule 624.  An  individual,  other  than  a  physician,  who  operates  a
mammography machine shall not do any of the following:
  (a) Perform mammography  without  the  supervision  of  the  mammography
supervisor.
  (b) Use a mammography machine  without  following  standing  orders  and
repeat film policies.
  (c) Make a diagnosis based on any radiograph or image.
  (d) Operate a mammography machine without having been trained to operate
the mammography machine safely and effectively.
  (e) Report any diagnosis to a patient, except as ordered by  a  licensed
physician.

  History:  1993 AACS.


R  325.5625   Program of mammography instruction; topics.
  Rule 625. A formal program of mammography instruction for  operators  of
mammography equipment shall include all of the following topics:
  (a) Anatomy and physiology of the female breast, including  all  of  the
following:
  (i) Mammary glands.
  (ii) External anatomy.
  (iii) Subdivision for localization.
  (iv) Retromammary space.
  (v) Central portion.
  (vi) Cooper's or suspensory ligament.
  (vii) Vessels, nerves, and lymphatics.
  (viii) Breast tissue.
  (b) Classification of breast tissue,  including  all  of  the  following
types of tissue:
  (i) Fibro-glandular.
  (ii) Fibro-fatty.
  (iii) Fatty.
  (iv) Lactating.
  (c) Epidemiology of breast cancer, breast cancer detection methods,  and
information sources.
  (d) Influence of technical factors.
  (e) Positioning of the breast, including all of the following:
  (i) Cranio-caudal.
  (ii) Medio lateral oblique.
  (iii) Axillary.
  (iv) Magnification.
  (v) Errors in positioning.
  (vi) Special techniques for mammography for the postoperative breast and
the augmented breast.
  (vii)  Special  radiographic  techniques  for  breast  localization  and
specimen radiography.
  (viii) Special techniques for additional mammography projections.
  (f) Film  or  image  evaluation  and  critique,  including  all  of  the
following:
  (i) Optimum mammographic images, including all of the following:
  (A) Radiographic density.
  (B) Radiographic contrast.
  (C) Definition.
  (D) Distortion.
  (E) Positioning.
  (ii) Detection of pathology.
  (iii) Benign and malignant lesions.
  (iv) Mass lesion borders as smooth, irregular, or with calcification.
  (g) Radiation biology and radiation protection.
  (h) Quality assurance.

  History:  1993 AACS.


                            RADIATION PHYSICIST


R  325.5631   Qualifications.
  Rule 631. (1) A radiation physicist shall be certified in diagnostic  or
radiological physics by the American board of radiology or by the American
board of  medical  physics  or  shall  meet  equivalent  requirements,  as
determined  by  the  department,  to  be  qualified  to  provide   on-site
consultation  and  evaluation  of  mammography  systems   to   mammography
facilities.
  (2) "Equivalent requirements," as used in  subrule  (1)  of  this  rule,
means that all of the following factors have been satisfied:
  (a) The radiation physicist possesses either of the following:
  (i) A bachelor's degree in physics or applied physics or in  a  physical
science with the equivalent of a physics minor and, in addition, 11  years
of work experience in diagnostic radiological physics.
  (ii) A masters or doctoral degree in medical physics or physics or in  a
physical science with the equivalent of a physics minor and, in  addition,
3 years of work experience in diagnostic radiological physics.
  (b) Work experience in diagnostic radiological physics shall  have  been
performed under the supervision of a certified diagnostic or  radiological
physicist or a radiologist who is  certified  by  the  American  board  of
radiology or the American osteopathic board of radiology.
  (c) References have been provided  listing  the  names  of  a  physician
certified in radiology and a physicist who is certified in  diagnostic  or
radiological physics, 1 of whom has  directed  the  individual's  training
specified in subdivision (b) of this subrule.
  (3) To be qualified to provide on-site consultation  and  evaluation  of
mammography systems to mammography facilities, a radiation physicist shall
meet all of the following requirements on a continuing basis  in  addition
to the requirements specified in subrule (1) or (2) of this rule:
  (a) Submit evidence, acceptable to the department, of formal training or
experience in  medical  physics  and  in  the  evaluation  of  mammography
systems.
  (b) Demonstrate competence in performing,  recording,  and  interpreting
the results of required quality control checks.
  (c) Submit a sample of a mammography evaluation report, or the  contents
of a report, to the department for approval.
  (d) Have appropriate testing equipment available to perform the  medical
physics quality control checks required by R 325.5632(3).
  (4)  In  evaluating  the  qualifications  pursuant  to  this  rule,  the
department shall establish an advisory committee of qualified  mammography
physicists to evaluate the submitted credentials. The department may  rely
on their expert evaluation in arriving at a department decision  regarding
the acceptability of the individual's qualifications.

  History:  1993 AACS.


R  325.5632   Mammography system evaluation.
  Rule 632. (1) At least annually, each mammography facility shall have  a
qualified radiation physicist  provide  an  on-site  consultation  to  the
facility, including a complete evaluation of the entire mammography system
to ensure compliance  with  the  provisions  of  the  act  and  the  rules
promulgated under the act. This evaluation of the mammography system shall
be in addition to the annual regulatory inspection that  is  conducted  by
the department as prescribed by R 325.5603.
  (2)  The  mammography  facility  shall  make  and  document  appropriate
corrections to  any  item  found  during  the  annual  mammography  system
evaluation by a radiation physicist that does not meet the requirements of
these rules.
  (3) The items to be inspected and evaluated during on-site consultations
shall include all of the following:
  (a) Mammography machine performance to  determine  compliance  with  the
provisions of R 325.5637 to R 325.5652.
  (b) Measurement  of  skin  exposure  for  a  cranio-caudal  view  for  a
4.5-centimeter compressed breast that is composed of 50% glandular and 50%
adipose tissue. For equipment that has an automatic exposure control,  the
measurement shall be made with a mammography phantom which  has  a  serial
numbered wax insert and which is used in the American college of radiology
accreditation program or a phantom that is deemed to be equivalent by  the
department in the x-ray beam.
  (c) Calculation of the average or mean glandular dose per  cranio-caudal
view of a  4.5-centimeter  compressed  breast  that  is  composed  of  50%
glandular and 50% adipose tissue. The mean glandular  dose  shall  not  be
more than any of the values specified in R 325.5661.
  (d) Evaluation of an image of a mammography phantom which has  a  serial
numbered wax insert and which is used in the American college of radiology
accreditation program, or an alternate phantom that  is  approved  by  the
department, using exposure  techniques  for  a  cranio-caudal  view  of  a
4.5-centimeter compressed breast that is composed of 50% glandular and 50%
adipose  tissue.  The  image  of  the  mammography  phantom  shall  be  in
compliance with the criteria prescribed by R 325.5660.
  (e) Measurement of the equivalent focal spot resolution,  both  parallel
and perpendicular to the anode-cathode axis with a focal spot test device.
  (f) Evaluation of the performance  of  the  automatic  exposure  control
system with regard to all of the following:
  (i) Reproducibility.
  (ii)  Performance  capability,  including  kilovoltage   and   thickness
compensation.
  (iii) Density control function.
  (g) Evaluation of the darkroom for integrity and  safelight  conditions.
  (h) Review of the film processing quality control records, including all
of the following:
  (i) Medium density.
  (ii) Density difference.
  (iii) Base plus fog.
  (iv) Developer temperature.
  (i) For screen-film mammography, evaluation of  the  uniformity  of  the
radiographic speed of each  cassette-screen  that  is  normally  used  for
mammography. For each cassette-screen of a given class  of  screen  speed,
the ratio of the optical density of a test image to  the  average  optical
density of the test images shall fall within the range of 0.9 to 1.1.

  History:  1993 AACS.


R  325.5633   Records of on-site evaluations and consultations.
  Rule 633. Records of on-site  evaluations  and  consultations  shall  be
provided  and  maintained  in  accordance  with  both  of  the   following
provisions:
  (a) Records of evaluations and consultations performed pursuant  to  the
provisions of R 325.5605(e) shall be provided to the mammography facility.
The records shall be provided within  30  days  after  completion  of  the
evaluation and consultation. The records shall clearly indicate all of the
following information:
  (i) The tests, evaluations, and consultations  performed  and  the  date
these occurred.
  (ii) The name  of  the  person  or  persons  who  performed  the  tests,
evaluations, and consultations.
  (iii) The results of the tests, evaluations, and consultations.
  (iv) The  testing  equipment  used,  including  the  date  of  the  last
calibration of radiation detection equipment  or  cross-calibration  to  a
calibrated instrument.
The records shall be in a format that is approved by the department. These
records shall be maintained by the mammography facility for not less  than
7 years.
  (b) Copies of records that are provided to mammography facilities  shall
also be maintained by the person who performed the tests, evaluations, and
consultations. These records shall be  maintained  for  not  less  than  7
years. Copies of the records shall be made available  for  examination  by
the department and, if requested in  writing  by  the  department,  copies
shall be forwarded to  the  department  within  30  days  of  the  written
request.

  History:  1993 AACS.


                              X-RAY EQUIPMENT


R  325.5637   Compliance with provisions of R 325.5325; machine design.
  Rule 637. (1) The mammographic x-ray equipment shall  be  in  compliance
with the requirements of R 325.5325(1) and (17) to (23).
  (2) The machine that is  used  for  mammography  shall  be  a  radiation
machine that is specifically designed to perform mammography.

  History:  1993 AACS.


R  325.5638   Machine output.
  Rule 638. (1) Mammography  machines  shall  generate  a  high-frequency,
constant-potential, 3-phase, or equivalent output.
  (2) Mammography machines shall be capable of an output at  28  kilovolts
of not less than 500 milliroentgens per second at breast  entrance  for  a
4.5-centimeter compressed breast with the compression plate  in  the  beam
for any mammographic technique that is used other than  for  magnification
techniques.

  History:  1993 AACS.


R  325.5639   Accuracy of technique factors.
  Rule 639. (1) The deviation of peak tube potential from indicated values
shall  not  be  more  than  5%  in  the  useful  mammographic  range.  The
coefficient of variation for peak tube potential reproducibility shall not
be more than 5%, and a determination of compliance shall be based  on  not
less than 4 consecutive measurements.
  (2) For machines with timer controls, the  deviation  of  exposure  time
from indicated values shall not be more than 5%  for  exposures  that  are
more than 100 milliseconds and shall not deviate more than 10 milliseconds
for shorter exposure times. The  coefficient  of  variation  for  exposure
timer reproducibility shall not be more than 5%  and  a  determination  of
compliance shall be based on not less than 4 consecutive measurements.

  History:  1993 AACS.


R  325.5640   Permissible degree of coefficient of variation of  radiation
exposure for combination of selected technique factors.
  Rule 640. For any specific combination of  selected  technique  factors,
the coefficient of variation of radiation exposures shall be  not  greater
than 5%. A determination of compliance shall be based on not less  than  4
consecutive measurements.

  History:  1993 AACS.


R  325.5641   Permissible difference in  average  ratios  of  exposure  to
indicated  milliampere-seconds  product  obtained   at   2   consecutive
settings.
  Rule  641.  The  average   ratios   of   exposure   to   the   indicated
milliampere-seconds product, or mR/mAs, obtained at any 2  consecutive  mA
or mAs settings shall not differ by more than 0.10 times their  sum.  That
is: 'X1 - X2'<0.10 (X1 + X2); where X1  and  X2  are  the  average  mR/mAs
values that are obtained at each of 2 consecutive mA or mAs settings.

  History:  1993 AACS.


R  325.5642   Target and filter material.
  Rule 642. (1) For screen-film mammography, the target  material  of  the
x-ray tube shall be molybdenum with molybdenum filtration and a  beryllium
window. Exceptions may be granted for other combinations if beam  quality,
imaging  capabilities,  and  patient  dose   are   consistent   with   the
requirements of this part.
  (2) For xeromammography, the target material of the x-ray tube shall  be
tungsten with aluminum filtration. Exceptions may  be  granted  for  other
combinations if beam quality, imaging capabilities, and patient  dose  are
consistent with the requirements of this part.

  History:  1993 AACS.


R  325.5643   Nominal focal spot size.
  Rule 643. (1) The nominal focal spot size of any  available  focal  spot
shall not be more than any of the following values:
  (a) 0.6 at a source-image receptor distance of 80 centimeters  or  more.
  (b) 0.5 at a source-image receptor distance of 65 to 79 centimeters.
  (c) 0.4 at a source-image receptor distance of 50 to 64 centimeters.
  (2) The focal spot dimensions, both parallel and  perpendicular  to  the
anode-cathode  axis,  shall  be   in   compliance   with   vendor-provided
specifications   and   national   electrical   manufacturers   association
specifications.

  History:  1993 AACS.


R  325.5644   Half-value layer.
  Rule 644. (1) The  half-value  layer  for  a  screen-film  system  at  a
measured tube potential of 30  kilovolts  shall  not  be  less  than  0.30
millimeter of aluminum and shall not  be  more  than  0.42  millimeter  of
aluminum. It is recommended that the half-value layer  be  not  more  than
0.40 millimeter of aluminum at a measured tube potential of 30  kilovolts.
The half-value layer shall be measured with the compression device in  the
x-ray beam.
  (2) The half-value layer for xeromammography shall not be less than  1.0
millimeter of aluminum and shall not  be  more  than  2.0  millimeters  of
aluminum at the clinically employed peak tube potential.
  (3) Positive  means  shall  be  provided  to  insure  that  the  minimum
filtration that is needed to achieve the  beam  quality  requirements  set
forth in this rule is in the useful beam during each exposure.

  History:  1993 AACS.


R  325.5645   Focal spot to image receptor distance.
  Rule 645. The focal spot to image receptor distance shall  not  be  less
than 50 centimeters.

  History:  1993 AACS.


R  325.5646   Machine design; x-ray beam geometry.
  Rule 646. A mammography machine shall be designed so that the  plane  of
the useful beam that is adjacent to the chest  wall  is  parallel  to  the
chest wall and is perpendicular to the plane of the image receptor for all
cassette sizes.

  History:  1993 AACS.


R  325.5647   Reciprocating grid capability; grid ratio;  exception;  grid
lines.
  Rule 647. (1) Each mammography machine  that  is  used  for  screen-film
mammography shall be capable  of  using  a  reciprocating  grid  for  each
available film size. The grid ratio shall be less than or  equal  to  5:1.
Exceptions  may  be  granted  for  ratios  higher  than  5:1  if   imaging
capabilities and patient dose are consistent with these rules.
  (2) Grid lines shall not be apparent on clinical or mammography  phantom
images.

  History:  1993 AACS.


R  325.5648   Image receptor capability.
  Rule 648. Each location or  address  where  screen-film  mammography  is
performed shall have the capability of using both an 18  by  24-centimeter
image receptor and a 24 by 30-centimeter image receptor.

  History:  1993 AACS.


R  325.5649   Beam limiting device.
  Rule 649. Each mammography machine shall  have  a  means  to  limit  the
useful beam so that the x-ray field at the plane  of  the  image  receptor
does not extend beyond any edge of the image receptor  at  any  designated
source-image receptor distance (SID) other than  the  edge  of  the  image
receptor that is designed to be adjacent to  the  chest  wall.  The  x-ray
field shall not extend beyond the edge  of  the  image  receptor  that  is
designed to be adjacent to the chest wall by more than 2% of the SID. Each
fixed aperture,  beam-limiting  device  shall  have  clear  and  permanent
markings to indicate the image receptor size  and  SID  for  which  it  is
designed. For systems that are equipped with a light localizer, the  light
field shall be aligned with the x-ray field to within 2% of the SID.

  History:  1993 AACS.


R  325.5650   Compression device.
  Rule 650. Each mammography machine shall have a compression device.  For
screen-film mammography, the compression device shall be of the flat plate
type. For xeromammography, a contoured compression paddle may be used  and
balloons shall not be used for compression.

  History:  1993 AACS.


R  325.5651   Primary  beam  transmission  through  the   image   receptor
support.
  Rule 651. The  transmission  of  the  primary  beam  through  any  image
receptor support provided with the system shall be  limited  so  that  the
exposure 5 centimeters from  any  accessible  surface  of  the  supporting
device beyond the plane of  the  image  receptor  is  not  more  than  0.1
milliroentgen for each activation of the tube. Exposure shall be  measured
with the system operated at the minimum source-image receptor distance for
which it is designed. Compliance shall be determined at the  maximum  peak
tube potential clinically employed for the system and extrapolated to  the
maximum rated product of the tube current and exposure time for that  peak
tube potential.

  History:  1993 AACS.


R  325.5652   Automatic exposure control system.
  Rule 652. (1) Each screen-film mammography  machine  shall  be  provided
with an automatic exposure control system.
  (2) The automatic exposure control system  for  screen-film  mammography
shall provide a coefficient of variation that is  not  more  than  5%  for
exposure or image optical density. A determination of compliance shall  be
based on not less than 4 consecutive measurements with  4  centimeters  of
acrylic or BR-12 attenuator in the beam.
  (3) One year after the  effective  date  of  this  part,  the  automatic
exposure control system for screen-film mammography shall  maintain  image
optical density to within plus  or  minus  0.30  of  the  average  as  the
kilovoltage  is  varied  within  the  clinically  employed  range  and  as
attenuator thickness is varied from 2 centimeters  to  6  centimeters  for
each clinically employed kilovoltage. Two years after the  effective  date
of this part, the automatic exposure control system shall  maintain  image
optical density to within plus  or  minus  0.20  of  the  average  as  the
kilovoltage  is  varied  within  the  clinically  employed  range  and  as
attenuator thickness is varied from 2 centimeters  to  6  centimeters  for
each clinically employed kilovoltage. Compliance with this subrule is  not
required for specific attenuator  thickness/kilovoltage  combinations  if,
during the test with those attenuator thickness/kilovoltage  combinations,
the maximum automatically controlled exposure limit  is  reached,  causing
the test films to have an optical density lower  than  the  standard.  The
attenuator that is used for determining compliance shall be either acrylic
or BR-12 material.
  (4) The automatic exposure control system  for  screen-film  mammography
shall  limit  the  maximum  automatically  controlled  exposure   to   750
milliampere-seconds.
  (5) One year after the effective date of  this  part,  each  mammography
machine  shall  indicate,  or  provide  the  means  of  determining,   the
milliampere-seconds resulting from each exposure made with  the  automatic
exposure control.

  History:  1993 AACS.


R  325.5655   Enclosure requirements.
  Rule 655. (1) An x-ray equipment enclosure shall be in  compliance  with
the requirements of R 325.5331.
  (2) For mammography, the  operator's  barrier  shall  provide  radiation
protection that is equivalent to not less than 0.5 millimeter of lead when
the maximum potential is limited electrically or mechanically to less than
or equal to 35 kilovolts and 0.8  millimeter  of  lead  when  the  maximum
potential is more than 35 kilovolts.

  History:  1993 AACS.


R  325.5656   Operation requirements.
  Rule 656. (1) The operation of each mammography x-ray machine  shall  be
in compliance with the requirements of R 325.5333.
  (2) Mammograms shall be retained for not less than 7 years or  shall  be
given to another person for placement in the patient's medical  record  as
directed by the patient or the primary care provider.

  History:  1993 AACS.


                              QUALITY CONTROL


R  325.5659   Quality    control    responsibilities    of     supervisor;
establishment of quality  assurance  manual;  provision  of  mammography
phantom; submission of phantom images.
  Rule  659.  (1)  A  mammography  supervisor  shall  be  responsible  for
maintaining a quality control program and for insuring the standardization
of quality control methodology. This responsibility may be delegated to  a
quality control technologist, although the mammography supervisor shall be
ultimately responsible.
  (2) A mammography facility shall establish a written  quality  assurance
manual, which shall include all of the following:
  (a) The quality control tests to be performed.
  (b) The frequency of each quality control test.
  (c) The forms to be used to record the results of  the  quality  control
tests.
  (d) The limits of acceptability of each quality control test.
  (e) A protocol for making corrections when a quality control  test  does
not fall within the limits of acceptability. The quality assurance  manual
shall be available at the facility for examination by the department.
  (3) The owner or person who is in control of mammography x-ray equipment
shall provide a mammography phantom at  each  location  or  address  where
mammography is performed. The phantom shall be a mammography phantom which
has a serial numbered wax insert and which is used in the American college
of radiology accreditation program or any other  phantom  that  is  deemed
appropriate and acceptable by the department.
  (4) Upon written request  by  the  department,  a  mammography  facility
shall,  for  each  of  its  mammography  x-ray  machines,  submit  to  the
department an x-ray image of a mammography  phantom  which  has  a  serial
numbered wax insert and which is used in the American college of radiology
accreditation  program  or  other  department-approved  phantom  taken  at
routine machine settings used for a 4.5-centimeter compressed breast  that
is composed of 50% glandular and 50%  adipose  tissue.  For  each  phantom
image that is submitted to the department, the facility shall specify  all
of the following information:
  (a) The serial number of the phantom.
  (b) The registration number of the x-ray machine.
  (c) The machine settings used, such as kilovoltage, milliamperage, time,
and density setting.
  (d) The type of x-ray film and intensifying screens used.

  History:  1993 AACS.


R  325.5660   Phantom image quality.
  Rule 660. The quality of an image of a mammography phantom which  has  a
serial numbered wax insert and which is used in the  American  college  of
radiology accreditation program,  or  other  department-approved  phantom,
taken  at  clinically  employed  machine  settings  for  a  4.5-centimeter
compressed breast that is  composed  of  50%  glandular  and  50%  adipose
tissue, shall be in compliance with  all  of  the  following  criteria  as
determined by the department:
  (a) Each fibril down to and including the 0.75-millimeter  fibril  shall
be visualized.
  (b) Each mass down to and including the 0.75-millimeter thick mass shall
be visualized.
  (c) All specks in each group down to and including  the  0.32-millimeter
speck group shall be visualized.

  History:  1993 AACS.


R  325.5661   Radiation dose limits.
  Rule 661. The  mean  glandular  dose  for  a  cranio-caudal  view  of  a
4.5-centimeter compressed breast that is composed of 50% glandular and 50%
adipose tissue shall not be more than any of the following values:
  (a) Screen-film without grid: 100 millirads per view.
  (b) Screen-film with grid: 200 millirads per view.
  (c) Xeromammography: 400 millirads per view.

  History:  1993 AACS.


R  325.5662   Screen-film processor adjustment.
  Rule 662. A processor for screen-film mammography shall be  adjusted  to
optimize image quality.

  History:  1993 AACS.


R  325.5663   Mammography phantom  imaging  required;  corrective  action;
phantom imaging for mobile units; repeat analysis; compression check.
  Rule 663. (1) A mammography phantom which  has  a  serial  numbered  wax
insert  and  which  is  used  in  the  American   college   of   radiology
accreditation program, or  other  department-approved  phantom,  shall  be
imaged at least monthly at machine settings that are normally used for  an
average patient with 4.5-centimeter compressed breasts that  are  composed
of 50% glandular and 50% adipose tissue. The facility  shall  maintain  an
available file of such images for inspection by  the  department  and  for
comparison with earlier images to note changes in image  quality.  If  the
phantom image does  not  meet  the  criteria  prescribed  by  R  325.5660,
corrective action shall be taken. After corrective action and  before  the
machine is used on  a  patient,  an  additional  phantom  image  shall  be
obtained to demonstrate compliance  with  R  325.5660.  Each  operator  of
mammography  equipment  shall  also  be  familiar  with  phantom   imaging
procedures and the use of the phantom as a method  of  evaluating  machine
performance.
  (2) After each relocation of a mobile unit  or  transportable  van,  and
before the machine is used on a patient, a mammography phantom  image,  at
machine settings that are  normally  used  for  an  average  patient  with
4.5-centimeter compressed breasts that are composed of 50%  glandular  and
50% adipose tissue, shall be made for comparison with  earlier  images  to
assure the proper functioning of the  mammography  system.  The  resultant
milliampere-seconds  shall  be  recorded  and  compared  with   the   mean
milliampere-seconds   determined   from   the   most    recent    exposure
reproducibility  test  of  the  automatic  exposure  control  system.  The
facility shall maintain an available file of the images for inspection  by
the department and for comparison with earlier data  to  note  changes  in
mammography system performance. Mammograms and  phantom  images  shall  be
processed within 24 hours of being obtained. If the phantom images do  not
meet  the  criteria  prescribed  by  R  325.5660  or  if   the   resultant
milliampere-seconds  is  not  within  plus  or  minus  15%  of  the   mean
milliampere-seconds   determined   from   the   most    recent    exposure
reproducibility test of the automatic exposure control system,  corrective
action shall be taken.
  (3) A repeat analysis shall be performed at least quarterly, or, for low
volume practices, after 250 patients, by comparing the number of  rejected
or repeated films to the total number of films that were used  during  the
test period.
  (4) Compression in the manual and powered  modes  shall  be  checked  at
least semiannually. The maximum compression force shall be not  less  than
25 pounds nor more than 40 pounds in the power drive mode.

  History:  1993 AACS.


R  325.5664   Screen-film mammography quality control.
  Rule  664.  All  of  the  following  quality  control   procedures   for
screen-film mammography shall be performed at the indicated intervals  and
when components are initially  placed  into  service,  when  problems  are
suspected, or after service or preventive maintenance:
  (a) The darkroom that is used for  mammography  shall  be  cleaned  each
operational day before processing or handling any films.
  (b) A facility shall  have  a  sensitometer,  densitometer,  non-mercury
thermometer, and control charts or  computerized  control  charts  readily
available to perform and record the  required  processor  quality  control
tests. The control film shall  be  of  the  same  type  that  is  used  in
mammography.
  (c) A facility shall conduct processor  quality  control  tests  at  the
beginning of each operational day before processing any patient films. The
tests shall include measuring and  plotting  all  of  the  following  data
points:
  (i) Medium density, which is the optical density of a particular step on
the sensitometric step wedge, which is determined during the establishment
of processor quality control operating levels, and which  has  an  average
density closest to 1.20.
  (ii) Density difference, which is  the  difference  in  optical  density
between 2 consistently chosen sensitometric steps. These steps, which  are
determined during the establishment of processor quality control operating
levels, shall be the step that has a density closest to 2.20 and the  step
that has a density closest to, but not less than, 0.45.
  (iii) Base-plus-fog, which is the optical  density  from  the  unexposed
area of the sensitometric film.
  (iv) Developer temperature.
  (d) Processor quality  control  operating  levels  for  medium  density,
density difference, and base-plus-fog shall be determined  over  not  less
than  5  consecutive  days  after  the  processor  is  cleaned.  Developer
temperature shall be set at the temperature that is specified in the  film
manufacturer's written literature.
  (e) The medium density and density difference shall be  within  plus  or
minus 0.10 of their respective operating  levels,  and  the  base-plus-fog
shall be within plus or minus 0.03 of its operating level. If  the  medium
density or density difference falls outside of  the  plus  or  minus  0.10
control limits, but is within plus  or  minus  0.15,  the  test  shall  be
repeated immediately.  If  the  same  result  is  obtained,  it  shall  be
acceptable to process clinical films, but the processor shall be monitored
closely. If the medium density or density difference exceeds  the  control
limits of plus  or  minus  0.15,  the  source  of  the  problem  shall  be
determined and corrected before clinical mammograms are processed in  that
processor. If the base-plus-fog exceeds the control limit of plus or minus
0.03,  immediate  corrective  action  shall  be  taken   before   clinical
mammograms are processed.
  (f) The processor crossover rollers shall be  cleaned  each  operational
day.
  (g) Mammography intensifying screens shall be cleaned  at  least  weekly
using the manufacturer's recommended materials and procedures. The outside
of film cassettes shall be checked or cleaned at least monthly.
  (h)  Mammography  darkroom  fog  shall  be  checked  semiannually,  when
safelight filters or bulbs are changed, or when  fog  is  suspected.  Film
that is exposed to visible light with a sensitometer and then exposed  for
2 minutes in the darkroom shall not  produce  more  than  a  0.05  density
increase in the mid-density of 1.30 to 1.40 optical density portion of the
sensitometric strip.
  (i) Mammography screen-film contact shall be checked semiannually.
  (j) Mammography clinical images shall be interpreted in subdued  ambient
lighting conditions on a view box that is masked to reduce glare. View box
surfaces shall be cleaned weekly.

  History:  1993 AACS.


R  325.5665   Xeromammography; plate management system.
  Rule 665. (1) Each facility that utilizes xeromammography shall maintain
a plate management system  to  track  suspected  plate  artifacts.  If  an
artifact is observed on an image, the facility  shall  record  the  serial
number of the suspect plate,  the  type  of  artifact,  and  the  date  of
observance of the artifact. The suspect plate shall be cycled through  the
system for reevaluation or removed from service. If  on  reevaluation  the
artifact is determined to be reproducible and to be significant enough  to
affect diagnostic quality, that plate shall be removed from service.
  (2) Dark dusting of each newly installed plate shall be performed before
the plate is put into service to evaluate the plate  for  artifacts.  Dark
dusting means processing a charged plate without exposing  the  plate.  If
artifacts that would affect diagnostic quality are noted, the  plate  that
has the noted artifacts shall not be put into service.

  (3) If artifacts are observed that are not plate-related, the source  of
the problem shall be determined and corrected.

  History:  1993 AACS.